Type 2 DiabetesPhase 1JSMADNCT01217905
Japanese Single and Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic (PK) & Pharmacodynamic (PD) Study of AZD7687
A Phase 1 study testing AZD7687 in people with Type 2 Diabetes and Obesity, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound AZD7687. It will also assess how the body handles the drug and how it responds to the drug following single dose followed by multiple dosing over 7 days. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- AZD7687
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2010to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Suitable veins for cannulation or repeated venipuncture
- Have a body mass index (BMI) between 19 and 35 kg/m2 and weigh at least 50 kg and no more than 90 kg
- Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD7687 After Administration of Single and Multiple Ascending Doses in Healthy Male Japanese Subjects
This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound AZD7687. It will also assess how the body handles the drug and how it responds to the drug following single dose followed by multiple dosing over 7 days.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- AZD7687
- Keywords
- Phase 1, Type 2 diabetes, obesity, Japanese healthy volunteer, AZD7687
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7687Drug
Oral suspension
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD7687 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the safety and tolerability of AZD7687 following administration of single and multiple doses
Measured: From screening period to follow-up visit 45 days (Maximum).
Secondary outcomes (1)
Evaluate the pharmacokinetics (PK) (plasma and urine) of AZD7687 and it´s glucuronic acid metabolite (AZ13128940) after single and multiple doses
Measured: Before dose and repeatedly to follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrike Lorch, MD MFPM FRCA, Principal investigator, Richmond Pharmacology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217905
- Sponsor's protocol ID
- D2710C00004
- Acronym
- JSMAD
- Status last verified
- Feb 2012
- First submitted
- 7 Oct 2010
- Last updated
- 13 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD7687 After Administration of Single and Multiple Ascending Doses in Healthy Male Japanese Subjects
- ClinicalTrials.gov ID
- NCT01217905
- Acronym / sponsor ID
- JSMAD / D2710C00004
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- Phase 1, Type 2 diabetes, obesity, Japanese healthy volunteer, AZD7687
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound AZD7687. It will also assess how the body handles the drug and how it responds to the drug following single dose followed by multiple dosing over 7 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD7687 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Suitable veins for cannulation or repeated venipuncture
- Have a body mass index (BMI) between 19 and 35 kg/m2 and weigh at least 50 kg and no more than 90 kg
- Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product
Key exclusion criteria (3 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD7687Oral suspension | Drug | 1 |
Primary outcome
Investigate the safety and tolerability of AZD7687 following administration of single and multiple doses
Time frame: From screening period to follow-up visit 45 days (Maximum).
1 secondary outcome
Evaluate the pharmacokinetics (PK) (plasma and urine) of AZD7687 and it´s glucuronic acid metabolite (AZ13128940) after single and multiple doses
Time frame: Before dose and repeatedly to follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrike Lorch, MD MFPM FRCA principal investigator
Richmond Pharmacology Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD7687 in people with Type 2 Diabetes and Obesity, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate the safety and tolerability of AZD7687 following administration of single and multiple doses (time frame: From screening period to follow-up visit 45 days (Maximum).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2012.